RecruitingPhase 1NCT07319364

A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

90 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Fecal microbiota transplantation (FMT) for people with antineoplastic agents, drug-related side effects and adverse reactions, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFecal microbiota transplantation (FMT)

Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.


Locations(1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, China

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NCT07319364


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